Improving Wellbeing in Ischemic Heart Disease: the Potential Efficacy of Digitally-delivered Psychological Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in health-related quality of life
研究概览
简要总结
The purpose of this research is to see if Heart Health Yoga (HHY) Program when added on to standard cardiac rehabilitation (CR) will improve overall wellbeing and quality of life for patients experiencing ischemic heart disease, heart problems caused by narrowed heart arteries.
详细描述
The overarching aim of this project is to evaluate the impact of adding a novel digitally-delivered wellbeing intervention, namely the Heart Health Yoga (HHY) program, on overall wellbeing and quality of life (QoL), cardiovascular risk markers, adherence to therapy, sleep quality, and recurrent hospitalizations amongst ischemic heart disease (IHD) patients undergoing cardiac rehabilitation (CR). This aim will be addressed through the following objectives:
Objective 1: Assess the clinical efficacy of the added digitally delivered HHY program compared to standard psychosocial intervention alone on overall wellbeing and QoL amongst IHD patients undergoing CR.
Aim 1 (Primary): To evaluate and compare the impact of the added digitally delivered HHY program versus standard psychosocial intervention alone on wellbeing and QoL, as assessed using the MacNew heart disease questionnaire, amongst IHD patients undergoing CR.
Objective 2: Assess the benefit of the added digitally delivered HHY program compared to standard psychosocial intervention alone on cardio-metabolic risk, therapy adherence, sleep quality, and recurrent hospitalization amongst IHD patients undergoing CR.
Aim 2 (Secondary): Assess and compare the impact of the added digitally delivered HHY program versus standard psychosocial intervention alone on cardio-metabolic risk (i.e. hs-CRP, AM cortisol, body weight, waist circumference, heart rate and blood pressure), therapy adherence (via weekly compliance questionnaire for HHY group, Medication Adherence Report Scale [MARS-5], Fitbit activity tracker), exercise capacity (6 minute walk test) and muscular strength (hand grip testing), sleep quality (measured using Fitbit), and recurrent hospitalizations (determined by 1 year hospital re-admission rates) amongst IHD patients undergoing CR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-65 years of age.
- •Willing and able to provide informed consent.
- •Have a computer and smartphone for access to study videos and online questionnaires, and willing and able to download Fitbit app.
排除标准
- •Unable to provide informed consent.
- •Orthopedic injury/limitation or any other contraindications to exercise.
- •Known active psychiatric conditions including bipolar disorder, schizophrenia, mania, obsessive compulsive disorder.
- •Active treatment with antipsychotic medications.
结局指标
主要结局
Change in health-related quality of life
时间窗: Baseline, 6 weeks
Measured in arbitrary units using the MacNew heart disease questionnaire. The MacNew heart disease measures health-related quality of life questionnaire using a global score.
次要结局
- High sensitivity C-Reactive Protein (CRP)(Baseline, 12 weeks)
- AM cortisol(Baseline, 12 weeks)
- Height(Baseline, 6 weeks, 8 weeks, 12 weeks)
- Blood pressure(Baseline, 6 weeks, 8 weeks, 12 weeks)
- Weight(Baseline, 6 weeks, 8 weeks, 12 weeks)
- Heart rate(Baseline, 6 weeks, 8 weeks, 12 weeks)
- Waist circumference(Baseline, 6 weeks, 8 weeks, 12 weeks)
- 6 minute walk test distance measured in meters(Baseline, 6 weeks, 8 weeks, 12 weeks)